HIAC 9703+ Pharmaceutical Particle Counter

HIAC 9703+ liquid sampler and PharmSpec Software for Parenteral Drug Final Product Testing to USP<787>, <788> & EP2.9.19

PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub-visible particle content using light obscuration in accordance with USP<787>, <788> and EP 2.9.19. Flexible calibration at multiple flow rates improves ease of sampling for varying sample viscosities and volumes. Ease of use and data integrity are prioritized in PharmSpec with features such as login credentials controlled by Microsoft Active Directory, multi-level user rights, automated pass/fail compendial reporting, comprehensive audit trail, and auto-flush routines for improved walkaway operation. In addition to the built-in compendial test routines, user-defined SOPs can be programmed into the counter using PharmSpec Software’s Procedure Builder.

  • PharmSpec software is 21 CFR Part 11 ALCOA compliant
  • Secure database is either sited on the local pc operating the HIAC 9703 sampler, or sited remotely on a networked server
  • Periodic database backup can be selected for additional database security
  • Specially designed vial clamp holds sample in place and small-bore sampling probe enables full application of USP<787> for protein based drug products, such as vaccines
  • As recommended in USP<788> and <787> the HIAC 9703+ sampler is specifically designed for use in a HEPA-filtered laminar airflow cabinet to reduce risk of contamination

Documentation and Application Notes

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HIAC 9703+ Liquid Particle Counter Features

Applications

  • Small volume injectable (SVI)
  • Large volume injectable (LVI)
  • Research & development
  • Troubleshooting
  • Stability testing

Sample management

  • Instant particle contamination notification
  • Small vial holder & tare volume conserves costly samples
  • Configurable flow rates & interchangeable sensors for 0.5 µm - 600 µm particle size detection
  • Interchangeable sample probes & syringes

Software

  • Program custom SOPs to eliminate manual counter configuration and pass/fail calculations
  • Multi-level security for 21 CFR Part 11 compliance
  • Automatic database backup & recovery loss feature protects valuable results and data

Support

  • Expert SOP & IQ/OQ validation services available
  • Routine onsite service available for maximum uptime
  • ISO 21501 compliant calibrations

HIAC 9703+ Liquid Particle Counter Specifications

Software PharmSpec 3
Industry Standards CE
Light Source Laser diffraction
Particle Size Analysis Range 1.3 - 150 μm
Concentration Range 0 to 18000 particles/mL
Operating System Windows® XP with Service Pack 3 or later; Windows® Vista with Service Pack 2 or later; Windows® 7 (32 bit)
Software PharmSpec 3
Temperature Range Operating temp range: 5°C to 40°C
Item Specifications Referenced 2089409-02

Running a Sample

 

Technical Documents